Clinical trials: Apnea
Obstructive Sleep Apnea
A Phase II Pilot Study of the Trillium Full Face Mask
This will be a single-center, open-label randomized crossover design pilot study to evaluate the clinical safety, clinical performance, and clinical benefit of the Trillium full face mask
- Trial name
- NCT06932055
- Testing
- Trillium Full Face Mask, AirFit F20
- Volunteers
- 40 people
- Sponsor
- Philips Clinical & Medical Affairs Global
OSA
Parallel-Arm Study to Compare AD109 to Placebo With Patients With OSA (SynAIRgy Study)
This is a Phase 3 Randomized Double-Blind Placebo-Controlled 6-month Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.
- Trial name
- NCT05813275
- Testing
- AD109
- Where
- 73 sites in United States, Canada
- Volunteers
- 646 people
- Sponsor
- Apnimed
OSA - Obstructive Sleep Apnea
Parallel Arm Trial of AD109 and AD504 In Patients With OSA
This is a phase 2 randomized double-blind placebo-controlled parallel-arm dose finding study to compare fixed dose combinations of AD109 and AD504 to atomoxetine or placebo in Obstructive Sleep Apnea.
- Trial name
- MARIPOSA (NCT05071612)
- Testing
- AD109, AD504, Atomoxetine Hydrochloride
- Where
- 25 sites in United States
- Volunteers
- 294 people
- Sponsor
- Apnimed
Excessive Daytime Sleepiness, Obstructive Sleep Apnea
Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study
The purpose of study JZP110-405 is to determine whether solriamfetol is effective at improving cognitive function in participants with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA) plus impaired…
- Conditions
- Excessive Daytime Sleepiness, Obstructive Sleep Apnea, Impaired Cognitive Function
- Trial name
- SHARP (NCT04789174)
- Testing
- Solriamfetol
- Where
- 28 sites in United States, Canada and 4 more
- Volunteers
- 59 people
- Sponsor
- Axsome Therapeutics, Inc.
Obstructive Sleep Apnea
Field Usability Study of Eclipse Mask
The study is designed to assess the usability of a novel CPAP human interface compared to a traditional nasal mask. Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd…
- Trial name
- NCT05559047
- Testing
- Eclipse mask
- Where
- 3 sites in United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Bleep, LLC
Obstructive Sleep Apnea
Simulated In-House Usability Study of Eclipse Continuous Positive Airway Pressure (CPAP) Device
The study is designed to assess the usability of a novel CPAP human interface compared to a traditional nasal mask. Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd…
- Trial name
- NCT05570747
- Testing
- Usability
- Where
- 3 sites in United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Bleep, LLC
Obstructive Sleep Apnea
Sleep Apnea Study in Adults Using DreamPort-Eclipse and a Traditional Nasal Mask
The Randomized Controlled Trial of Bleep DreamPort-Eclipse Study is a two-arm, randomized, prospective, non-blinded study to assess the effectiveness of the novel CPAP human interface design to improve leak, AHI, and pressure…
- Trial name
- NCT05818540
- Testing
- Eclipse novel CPAP mask, ResMed P-10 mask
- Where
- United States
- Volunteers
- 173 people, healthy volunteers welcome
- Sponsor
- Bleep, LLC
Obstructive Sleep Apnea
Evaluation of the F&P Caramel Nasal Mask, US, 2023
The purpose of this clinical investigation is to evaluate the performance and safety of the F\&P Caramel nasal mask in a home environment.
- Trial name
- NCT06060717
- Testing
- F&P Caramel
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
Evaluation of the F&P Toffee Nasal Pillows Mask, US, 2022
The purpose of this clinical investigation is to evaluate the performance and safety of the F\&P Toffee nasal pillows mask in a home environment.
- Trial name
- NCT05573763
- Testing
- F&P Toffee
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Fisher and Paykel Healthcare
Sleep Apnea, Sleep Disorder
TatchSleep as a Tool to Aid in Sleep Apnea Analysis
This is a single center, single-arm, quantitative study evaluating the efficacy of the TatchSleep wireless sensor patches as a tool to aid in sleep apnea analysis as compared to an overnight PSG evaluation.
- Trial name
- NCT04419714
- Testing
- TatchSleep
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Wesper Inc
Sleep Apnea Syndromes
Amara View Benchmark Study
This randomized crossover, benchmark clinical trial aims to compare the Philips Amara View and ResMed AirFit F40 minimal contact full face masks on patient preference of mask attributes and usage parameters.
- Trial name
- NCT06535932
- Testing
- Amara View Minimal Contact Full Face Mask, F40 Minimal Contact Full Face Mask
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Obstructive Sleep Apnea, Obesity
Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea
The purpose of this study is to evaluate the effect and safety of tirzepatide in participants with moderate to severe obstructive sleep apnea and obesity who are both unwilling or unable to use Positive Airway Pressure (PAP)…
- Trial name
- SURMOUNT-OSA (NCT05412004)
- Testing
- Tirzepatide
- Where
- 58 sites in United States, Australia and 8 more
- Volunteers
- 469 people
- Sponsor
- Eli Lilly and Company
Obstructive Sleep Apnea
Transcend Auto vs Commercially Available Device Clinical Evaluation for Treatment of Obstructive Sleep Apnea (OSA)
The purpose of this study is to determine whether the Transcend Auto is as effective in treating obstructive sleep apnea as another device that is already on the market.
- Trial name
- NCT01799265
- Testing
- Somnetics Transcend Auto, Respironics REMstar Auto with C-Flex
- Where
- 3 sites in United States
- Volunteers
- 41 people
- Sponsor
- Somnetics International, Inc.
Obstructive Sleep Apnea
TPAP for Comfort in OSA
TheraPAP is a prototype device (with full documented electrical and isolation safety) being developed by SleepRes for the treatment of obstructive sleep apnea (OSA) that can deliver either standard CPAP at a set pressure or what…
- Trial name
- NCT06264128
- Testing
- TPAP, CPAP
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- SleepRes Inc.
Obstructive Sleep Apnea
TheraPAP Equivalence Crossover Study
The present study, TheraEquivalence, is a Phase 2 crossover study designed to examine the efficacy and safety of TheraPAP (TPAP) vs. CPAP alone in the treatment of OSA.
- Trial name
- NCT06238362
- Testing
- TPAP, CPAP
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- SleepRes Inc.
Obstructive Sleep Apnea (OSA)
Safety and Tolerability of Gefapixant (MK-7264) in Participants With Obstructive Sleep Apnea (MK-7264-039)
The purpose of this study is to assess the safety and tolerability of multiple dose administration of gefapixant (MK-7264) in participants with moderate to severe obstructive sleep apnea (OSA).
- Trial name
- NCT03882801
- Testing
- Gefapixant
- Where
- 5 sites in United States, Belgium
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Obstructive Sleep Apnea
The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ
This investigation is designed to evaluate the performance (leak and comfort) as well as the participant's overall acceptance of the nasal pillows mask amongst Obstructive Sleep Apnea (OSA) participants.
- Trial name
- NCT02741635
- Testing
- New Nasal Pillows Mask
- Where
- New Zealand
- Volunteers
- 15 people
- Sponsor
- Fisher and Paykel Healthcare
Perennial Allergic Rhinitis, Obstructive Sleep Apnea
The Effects of Mometasone Furoate Nasal Spray in Subjects With Sleep-disordered Breathing (SDB) Associated With Perennial Allergic Rhinitis (Study P04726)
This is a Phase 4 randomized, placebo-controlled, parallel-group, single-center, double-blind study to evaluate the effects of mometasone furoate nasal spray (MFNS) in subjects with Sleep-disordered Breathing (SDB) associated…
- Conditions
- Perennial Allergic Rhinitis, Obstructive Sleep Apnea, Sleep Disorder
- Trial name
- NCT00359216
- Testing
- Mometasone furoate nasal spray
- Volunteers
- 30 people
- Sponsor
- Organon and Co
Sleep Apnea, Obstructive, Pulmonary Disease, Chronic Obstructive
A Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Participants With Moderate to Severe Obstructive Sleep Apnea, and in Adult and Elderly Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease
The primary purpose of the study is to determine whether lemborexant increases the apnea hypopnea index (AHI) on Day 8 of treatment in adult and elderly participants (adults greater than or equal to [>=] 45 to less than [<] 65…
- Conditions
- Sleep Apnea, Obstructive, Pulmonary Disease, Chronic Obstructive, Respiration Disorders
- Trial name
- NCT04647383
- Testing
- Lemborexant 10 mg
- Where
- 11 sites in United States
- Volunteers
- 63 people
- Sponsor
- Eisai Inc.
Obstructive Sleep Apnea
Crossover Trial of AD036 in Obstructive Sleep Apnea
This is a randomized, 3-Period, Placebo-Controlled, Crossover, phase 2 clinical study to examine the efficacy and safety of AD036 versus placebo or atomoxetine in patients with obstructive sleep apnea.
- Trial name
- NCT04445688
- Testing
- AD036, Atomoxetine
- Where
- 5 sites in United States
- Volunteers
- 62 people
- Sponsor
- Apnimed